Ethical Considerations In Adaptive Design Clinical Trials

An adaptive design clinical study is one that includes a prospectively planned opportunity for modification of one or more aspects of the study design and hypotheses based on interim analysis of study data. The overall objectives of an adaptive design approach are to make clinical trials more efficient, more informative, or more likely to demonstrate an effect of the investigational product. While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.28